Microfracture in Rotator Cuff Injury Repair

NCT ID: NCT02097901

Last Updated: 2017-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

SUSPENDED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2018-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The hypothesis is that microfractures in the footprint of the humerus will aid to improve the tendon healing to the bone. The aim of the study is to investigate whether the use of microfractures at the footprint of the rotator cuff will improve the tendon healing when reinserted. Patients undergoing surgery for a rotator cuff injury will be randomised to repair with or without microfracture.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rupture of the Rotator Cuff

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Microfracture

Rotator Cuff Repair AND Microfracture at rotatorcuff footprint

Group Type EXPERIMENTAL

Microfracture

Intervention Type PROCEDURE

Rotator Cuff Repair AND Microfracture

NO microfracture

Rotator cuff reinsertion without microfracture

Group Type ACTIVE_COMPARATOR

NO microfracture

Intervention Type PROCEDURE

Rotator Cuff Repair without microfracture

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Microfracture

Rotator Cuff Repair AND Microfracture

Intervention Type PROCEDURE

NO microfracture

Rotator Cuff Repair without microfracture

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

\- Patients over the age of 18 with a full thickness rotatorcuff rupture.

Exclusion Criteria

* Isolated rupture of the subscapularis
* Tendon atrophia
* Goutallier grade 3-4 fatty degeneration
* Fracture surgery in same shoulder
* Inflammatory or neurologic affection of shoulder
* Other disabling disease
* Unwilling to participate in study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Zealand University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Morten S. Wad

M.D

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Lars Blønd, M.D

Role: STUDY_DIRECTOR

Køge Sygehus

Gunner S Barfoed, M.D

Role: STUDY_DIRECTOR

Køge Sygehus

Thomas JN Sørensen, M.D

Role: STUDY_DIRECTOR

Køge Sygehus

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Køge Sygehus

Køge, Lykkebækvej 1, Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SJ-370

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Results of Rotator Cuff Repair
NCT01549912 COMPLETED